510(k) · Cleared
ClearedEuroimmun Anti-PLA2R Elisa (Igg)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Euroimmun Us, Inc. · PGV Anti-Phospholipase A2 Receptor
Cleared on Jun 27, 2014 as substantially equivalent to DEN140002 (Euroimmun US, 2014) after a 347-day review. Its family tree reaches back 1 generation to 2014.
- Decided
- Jun 27, 2014
- Review
- 347 days
- Class
- Class II
- Product code
- PGV
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to DEN140002 (2014). No later device cites it as a predicate yet.
- Root · 1 generation backDEN140002 Euroimmun Anti-PLA2R IfaEuroimmun US · 2014
- This deviceK132195 Euroimmun Anti-PLA2R Elisa (Igg)Euroimmun Us, Inc. · 2014
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | DEN140002 | Euroimmun Anti-PLA2R Ifa | Euroimmun US | 2014 | — |
| 0 (this device) | K132195 | Euroimmun Anti-PLA2R Elisa (Igg) | Euroimmun Us, Inc. | 2014 | — |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in PGV? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | DEN140002 | Euroimmun Anti-PLA2R Ifa Our reading of the summary gave K132379, which is not in FDA’s 510(k) list. The device the summary names is FDA’s De Novo DEN140002, Euroimmun Anti-PLA2R Ifa (Euroimmun US), granted May 29, 2014; older De Novo requests were first filed under a 510(k) number, so this links to the grant. | 2014 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Its one ancestor has no recall.
How does its category compare?
All PGV devicesPGV Anti-Phospholipase A2 Receptor: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, this device’s year, is highlighted.
FDA decisions per year · PGV
2in 2014
2026 to Oct 25, outlined.
Median 510(k) review, days · PGV
Too few PGV 510(k)s in any year since 2007 to give a median.
Recalls per year · PGV
No recall names PGV since 2007.
Adverse event reports per year · PGV
No MAUDE report names PGV since 2007.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 2 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The EUROIMMUN Anti-PLA2R ELISA (IgG) test kit is intended for the qualitative or semi-quantitative determination of IgG class autoantibodies against phospholipase A2 receptor (PLA2R1) in human serum. It is used as an aid in the diagnosis of primary memnbranous giomerulonephritis (pMGN), in conjunction with other laboratory and clinical findings.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K132195 · printed Nov 6, 2026
Cite this page
510(k) Report. “K132195: Euroimmun Anti-PLA2R Elisa (Igg).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K132195
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026